If you are a student please see here for guidance on applying for regulatory approvals.
You need:
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To define your research question (you can find some advice plus further links here)
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To consider PICO
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To check whether your project is research and whether it classes as a Clinical Trial of an Investigational Medicinal Product (CTIMP)
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To write a protocol detailing what you intend to do
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To identify and obtain funding (see here for further advice)
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To determine who will be the Chief Investigator and any local Principal Investigators and get their agreement for the roles
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To identify a sponsor and get their agreement to sign off your application
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To check whether your project is eligible for HRA approval
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To check whether any other regulatory approvals are necessary
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To consider whether you want to apply to be included in the CRN portfolio
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To identify whether your project has any Excess Treatment Costs (ETCs). You will need to apply for ETCs to be funded which is done through the Clinical Research Network. See below for further guidance
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To complete an IRAS form, get the appropriate electronic signatures and submit it along with all of the study documentation
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To complete an local information pack for each site type and submit it along with the IRAS form. When you liaise with sites you should send these documents, along with the Organisational Information Document, for the sites to confirm their capability and capacity to undertake the research. Please also copy in the NHS R&D contact which performs an advisory and oversight role. If you need help identifying sites, the NHS R&D contact can also help with this.
To conduct a research study in the NHS, which means either recruiting patients or staff through their role in the NHS, or using patient or staff data, or taking place on NHS premises, you will need to consult with the NHS organisation, which will need to confirm capability and capacity of the organisation to take part in the study. For research in primary care each GP practice you want to use as a research site or Participant Identification Centre (PIC) has to sign off to say they have capability and capacity. If your study is taking place in primary care in West Yorkshire you also need to liaise with us, the West Yorkshire R&D Team. We can advise practices on their side of the research process. We can also help you to identify sites. For other areas or for secondary or community care organisations please also see the R&D Forum to identify which NHS organisation will be able to offer you support.
If you are accessing NHS sites or patient records to undertake the research, you will probably need to apply for a Research Passport in order to get a Letter of Access which assures the NHS sites that you are appropriately checked and qualified. To get the application form or to find out more see the IRAS guide or contact research@bradford.nhs.uk.
For further useful links please see below.
Throughout the study
Any amendments, both substantial and non-substantial, should be notified by the researchers to us and to the HRA. Substantial amendments requiring REC review have to be sent to REC which approved your study originally. For non-substantial amendments or amendments for studies where REC review is not required, these should be sent to the HRA: hra.amendments@nhs.net. If your study was processed under the old, pre-HRA system, amendments still need to go through the HRA. To add a site you need to email the HRA to bring the study under their approval. To do this, you should email hra.amendments@nhs.net with the title “IRAS XXXXXX – request for pre-HRA approval study to come under HRA approval”. The full approved document set should also be sent, and for non-commercial studies adding new sites, you should also complete and attach an Organisation information document.
Once an amendment receives approval from the HRA and REC where applicable, the document set should be updated to all participating sites. Please read carefully the HRA amendment approval letter and REC favourable opinion which will inform you of any additional steps you need to take. Sites are not required to confirm acceptance of an amendment, but if they do not wish to implement it, they should notify the study sponsor immediately. It may help the sponsor if the site confirms receipt of an amendment - otherwise this can be implemented after 35 days.
Research teams should provide all sites with a contact who will be able to help sites/patients with any queries. They should also provide a procedure for reporting any adverse events. Audits can be conducted by sponsors, by any of the applicable regulatory bodies or by our team. These will involve checking of your documents and processes. Authorities such as the Medicines and Healthcare products Regulatory Authority (MHRA) can require paper copies of all relevant documents so you should make sure sites hold all documents in paper form.
After the study
After the study research teams usually ‘close down’ the participating sites to confirm the end of the study. Documents relating to the study should be kept throughout the study and follow up, and for as long as the study data is kept. Studies keep research data for some time after the completion of a study in case of audit, queries or long-term side effects. How long they keep data for is dependent on the nature of the study and the policies of the organisations involved and/or funders.